Kornimate/medical-research-clean huggingface dataset:
clinical study of cm338 in the treatment of immunoglobulin a nephropathy

Conditions: IgA Nephropathy

Summary: this study is a multicenter, randomized phase ii clinical study to evaluate efficacy and safety, while observing pharmacokinetic profiles, pharmacodynamic effects, and immunogenicity of cm338 in subjects with immunoglobulin a(iga) nephropathy.

in 1968, immunoglobulin a nephropathy (igan) was developed by french pathologist dr. jean berger and his colleague dr. nicole hinglais that what is described as glomerular "immunoglobulin a (iga)-immune globule" - immune globule protein g (igg) intercapillary deposition" of kidney disease, the main pathological feature of which is on the glomerulus iga deposition, usually accompanied by local cell proliferation and stromal dilation. since there is not enough specificity and spirit biomarkers of sensitivity, the only way to confirm the diagnosis is renal biopsy.

Eligibility criteria:
inclusion criteria: * male or female aged 18-75. * understand the nature of the study and sign the informed consent form voluntarily. * take effective contraception measures throughout the study period. exclusion criteria: * used other investigational drugs within 30 days before the first study administration. * with previous history of human immunodeficiency virus(hiv) infection. * treponema pallidum antibody positive in screening period. * may have active mycobacterium tuberculosis infection. * major surgery is planned during the study. * other reasons the investigator believes that the subject is not suitable to participate in this study.
indicators of quality care and services for adults with acute ischemic stroke in different types of hospitals in quebec : research protocol

Conditions: Ischemic Stroke

Summary: the goal of this study is to describe the performance of care and services offered to people hospitalized with ischemic stroke. more specifically, this study aims to answer the following questions: * is stroke care and service delivered to the population optimally? * are these services equitable, regardless of the hospital where the patient is hospitalized? * are all patients treated in the same way, regardless of individual characteristics such as age, sex or risk factors? an evaluation of the quality of practices will be carried out on the health records of patients hospitalized in different hospital centers in quebec such as a subspecialized center, a regional center and a center in a remote region. an in-depth analysis will also be conducted to determine whether certain individual patient characteristics may influence how they are managed during a stroke.


Eligibility criteria:
inclusion criteria: - adults 18 years old or over with ischemic stroke requiring hospitalization in an acute care unit or special stroke unit exclusion criteria: * adults with hemorrhagic stroke

Keywords: clinical and organizational quality incdicators practices assessment stroke acute phase interdisciplinarity
virtual reality in cognitive rehabilitation of processing speed for persons with abi

Conditions: Traumatic Brain Injury; Stroke; Acquired Brain Injury; Brain Injuries; Brain Diseases

Summary: one hundred participants with acquired brain injury (abi) will be included in a randomized controlled trial, with one group playing a commercially available vr game and the control group doing activities in their everyday as cognitive training. the trial aims to investigate how vr can affect processing speed in the abi population, and if these effects can transfer into everyday activities. the training will be performed in the participants homes, with assistance provided by the project group via phone or video conference. the training period will last five weeks. participant's cognitive functions will be measured with questionnaires and neuropsychological tests at the start of the training period, at the end of training and sixteen weeks after the start of the intervention. in depth experiences with vr as a training method will be gathered through performing focus group interviews with some of the participants from the vr group, in addition to self-reported questionnaires from all the participants.

a randomized controlled trial (rct) will be conducted where the experimental intervention is playing a commercial vr game. the vr group will follow a training regime of a 30 min vr session five times per week for 5 weeks. the control group will carry on with treatment as usual, in addition, participants will receive an information booklet covering cognitive training in everyday life. baseline and outcome measures in terms of neuropsychological assessment and questionnaires will be performed at baseline (t1), at the end of the intervention period (t2) and at the 16-week follow-up (t3). the vr group will train with a rhythm vr game that is considered as a good candidate for basic training of the multifaceted aspects of attention including speed of information processing, selection, sustained attention, shifting/dividing of attention, and working memory. the vr game is selected on the grounds of clinical experience with vr training of processing speed, attention and working memory, and is also suggested in research as suitable games for cognitive rehabilitation.

Eligibility criteria:
inclusion criteria: * patients in stable phase after acquired brain injury, minimum one year after injury * physically able to operate vr-technology * norwegian or english skills adequate to understand instructions, play the vr-games and to provide valid responses to assessment methods exclusion criteria: * severe aphasia affecting their understanding of instructions * apraxia affecting their ability to use vr-equipment * visual neglect * severe mental illness, substance abuse or co-existing neurological disorders

Keywords: tbi traumatic brain injury stroke acquired brain injury virtual reality vr cognitive rehabilitation
milk proteins, ambulatory blood pressure and vascular function

Conditions: Hypertension

Summary: epidemiological studies demonstrated an inverse associations between cardiovascular events and milk and dairy product consumption. evidence from human intervention studies suggests that both whey and casein may be effective in blood pressure-lowering, however there is limited data on the impact of milk proteins on vascular function. this research aims to compare the potential acute and chronic impacts of the two main milk proteins (whey and casein) with maltodextrin on blood pressure and vascular function. furthermore, the effects of these proteins on the markers of insulin resistance, lipid metabolism and inflammatory status will also be investigated in 'at-risk' individuals. this research includes both an acute and chronic intervention study which have been independently powered on the appropriate outcome measures. this has generated different sample size requirements for the two studies (actual participants on the acute study: n=27, and on the chronic study: n=38).


Eligibility criteria:
inclusion criteria: * a signed consent form * blood pressure: 120/80-159/99 * age: 30-77 years * bmi 20-40 kg/m2 * glucose \<7 mmol/l (not diagnosed with diabetes) * chol \<8 mmol/l * tag \<4 mmol/l * normal liver and kidney function * haemoglobin (\>110 g/dl women; 140g/dl men) exclusion criteria: * milk allergy, lactose allergy * coeliac disease * renal, gastrointestinal, respiratory, endocrine, liver disease or cancer * surgery in the previous 6 months * secondary hypertension * excess alcohol consumption (drinking \>28 unit/wk man; \>21 unit/wk women) * smoker * vegan * taking nutritional supplementation (e.g. fish oil, proteins) * anaemia

Keywords: milk proteins blood pressure vascular function
cesarean postoperative pain satisfaction

Conditions: Cesarean

Summary: hypothesis: there is no significant difference in cesarean patients' perceptions of overall pain management satisfaction between methods used for postoperative pain management.

there is a significant difference between cesarean patients' perceptions of advantages and disadvantages of three postoperative pain management methods identified by obstetrical patients. participants will be introduced to study by anesthesia personnel in labor and delivery. the subject will be informed of the desire for their input on their perceived satisfaction with their chosen method for post-operative pain management and will be asked to participate in an anonymous survey by their second day after surgery. they will be informed that this is voluntary. method of post-operative medication administration will be determined by attending physician to be either: epidural, ivpca, or oral medication. methods will be initiated in recovery room or the operative suite. subjects will be identified on a postpartum admission log and a screening log will be created for study purposes. informed consents will be obtained. the screening log entries will be numbered corresponding to a numbered survey. the screening log will contain demographic and other patient identifiers including age, ethnicity, parity, presence of labor prior to cesarean, admission status of baby, cost associated with method and presence of rescue drugs and costs of rescue drugs and method services. refusal information, exclusion criteria, and time/date of survey completion will also be recorded. this log will be maintained under lock and key.

Eligibility criteria:
inclusion criteria: * english speaking post-operative cesarean patients exclusion criteria: * cesarean patients with know fetal demise * general/local anesthetic method for cesarean
efficacy and safety of recombinant human insulin patch zjsrm2021

Conditions: type1diabetes; Type2 Diabetes

Summary: the aim of this study is to investigate the efficacy，safety， and tolerability of the recombinant human insulin patch zjsrm2021 in healthy subjects, type 1diabetes mellitus and type 2diabetes mellitus patients


Eligibility criteria:
inclusion criteria: * type 1or type 2 diabetes body mass index：19\~35kg/m2（include） hba1c≤11.0% diabetic duration of t1dm was ≥1 year, and the subjects received insulin injections during the past year .metformin and glycosidase inhibitors were also allowed. newly diagnosed t2dm or metformin-only, and the drug dose remained stable for ≥30 days. or t2dm patients withdrawed drug ≥30 days of drug after diagnosis. exclusion criteria: * other type diabetes use of other oral antidiabetics drugs within the 1 months prior to screening. with a history of malignant tumor. with acute or chronic infection. with evidence of major active psychiatric disorders. drug abuse or alcohol abuse. drunk too much tea or coffee(more than 2000ml per day). history of any drug allergies. anti-insulin antibody positive. participated in clinical trials within 3 months prior to signing the informed consent.

Keywords: insulin patch type 1 diabetes mellitus type 2 diabetes mellitus safety efficacy
efficacy of combining an inferior alveolar nerve block with a buccal infiltration

Conditions: Pulpitis

Summary: objective to compare the effectiveness of using both a combined technique of an inferior alveolar nerve block and buccal infiltration with that achieved by utilizing an inferior alveolar nerve block alone for endodontic treatment of mandibular molars with irreversible pulpitis. study design randomized clinical trial place and duration of study operative dentistry department of armed forces institute of dentistry rawalpindi, from 1st april 2020 to 31st september 2020. material and methods a total of 120 patients were enrolled in the study. sixty patients of group a received conventional inferior alveolar nerve block and sixty patients of group b received buccal infiltration along with conventional inferior alveolar nerve block.

patients of group a received inferior alveolar nerve block anesthesia. for this block, nerve was approached from the contra-lateral side of the oral cavity over the contralateral premolars. needle penetrated into the mandibular tissue on the average boundary of the mandibular ramus inside the pterygomandibular space and lateral to pterygomandibular fold, it advanced until bony surface was contacted. in the event that bony contact wasn't made inside 27-29 mm of needle infiltration, needle was pulled back somewhat, moved the needle further distally toward premolars. the needle was withdrew 1-2 mm after making bony contact, aspiration was performed, followed by 1.8 ml deposition of anesthetic solution. patients of group b received buccal infiltration as supplementary injection technique to conventional inferior alveolar nerve block, buccal infiltration was carried out. the needle was penetrated in buccal mucosa adjacent to mandibular 1st molar. after aspiration, 1.8ml of anesthetic solution was dumped in approximate time of 2 minutes using 2% lignocaine with 1:100,000 epinephrine. following time period of 15 minutes of injection, every patient was inquired about his/her lip numbness. patients who did not experience significant lip numbness within 15 minutes after the block was administered were excluded from the investigation and was considered ineffective. in case of positive lip numbness patient concerned teeth was isolated using rubber dam and a traditional access opening was started. patient was told to lift hand if any pain will occur while doing procedure. the patient was requested to mark pain on visual analogue scale (vas) after completion of treatment. absence of pain was indicated if patient scored his/her pain ≤ 3 on vas.

Eligibility criteria:
inclusion criteria: * mandibular molars with irreversible pulpitis (confirmed by positive response to ept) * patient age between 18 to 45 years * no medication taken 24 hours before treatment * both male and female patients exclusion criteria: * patients on analgesics or anti-inflammatory drugs * medically compromised patients * teeth with immature apices * retreatment cases * patients allergic to lignocaine * teeth with root resorption * teeth with necrotic pulp * apical abscess * pregnancy

Keywords: anesthesia inferior alveolar nerve infiltration
bolster: caregiver app to reduce duration of untreated psychosis

Conditions: Caregiver to a Young Adult With Early Psychosis

Summary: the proposed research project aims to develop and test a mobile health intervention designed to improve caregivers' illness knowledge and caregiving skills through interactive cognitive-behavioral modules, and through these improvements, reduce distress, improve coping, improve family communication, increase caregiver treatment facilitation and reduce duration of untreated psychosis. this clinical trial will involve a remote pilot randomized controlled trial comparing this new intervention to existing online caregiving support resources. analyses will determine whether this approach is acceptable and feasible, as well as explore its effectiveness and impact on key components of the cognitive model of caregiving.


Eligibility criteria:
inclusion criteria: * 18 years old or older * live in the united states * caregiver to a young adult with early psychosis, wherein early psychosis is defined as: (1) being between the ages of 18 and 30, and (2) within the past five years, the young adult first experienced: (2a) presence of psychotic symptoms represented by one or more of hallucinations, delusions, marked thought disorder, psychomotor disorder or bizarre behavior, as well as (2b) definite change of personality or behavior manifesting as two or more of the following: serious deterioration of function, marked social withdrawal, persistent self-neglect, episodic marked anxiety. * a positive screen according to the caregiver prime screen - revised (endorsed two or more responses of five or six ("somewhat"/"definitely" agree)) * own an apple iphone * self-identify as a caregiver of the affected person * the affected person is not enrolled in specialty mental health services (i.e. a program wherein the affected person can access psychiatry and counseling/therapy services), and has not been enrolled in such services for at least three months prior to screening. if an affected person is receiving one of these services, the caregiver reports that this is an inadequate level of care. exclusion criteria: * incarceration or long-term care setting for either the caregiver or identified affected young adult. * participant failed to demonstrate understanding of study details in comprehension screening process. * the affected person is unengaged in services, but only as a result of having completed or "graduated" from a specialty treatment program for psychosis.
bone mineral density study in patients with chronic obstructive pulmonary disease. diskus® inhaler is a trademark of the gsk group of companies.

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this study will last up to 3 years. you will visit the clinic up to 14 times. certain visits will include lung function tests and scans of your bones. the purpose of this study is to determine the effect of the steroid component of an inhaled product on bone mineral density in patients with chronic obstructive pulmonary disease (copd).


Eligibility criteria:
inclusion criteria: * established clinical history of copd. * baseline fev1 \<70% predicted normal, and fev1/fvc ratio of less than 70%. * smoking history of at least 10 pack-years, where both current and former smokers will be eligible. * must have at least one native, evaluable hip. exclusion criteria: * history of or evidence for metabolic bone diseases other than osteoporosis or osteopenia.

Keywords: osteoporosis bone mineral density osteopenia chronic obstructive pulmonary disease copd
octa and polypoidal choroidal vasculopathy

Conditions: Polypoidal Choroidal Vasculopathy

Summary: to investigate the structural and vascular features of choroid in patients affected by pcv after ranibizumab intravitreal injection.

polypoidal choroidal vasculopathy represents a distinct form of choroidal neovascularization. the study investigated the changes in choroidal vascular network after anti-vegf therapy using optical coherence tomography angiography, a novel and non invasive diagnostic technique that allows to better understand the pathophysiologic mechanism of this neovascularization.

Eligibility criteria:
inclusion criteria: * age older than 60 years * diagnosis of polypoidal choroidal vasculopathy * absence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases. * absence of significant lens opacities, low-quality oct-a images. exclusion criteria: * age older than 80 years * absence of diagnosis of polypoidal choroidal vasculopathy * presence of previous ocular surgery, congenital eye disease, high myopia (\>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases. * presence of significant lens opacities, low-quality oct-a images.
thrombelastographic haemostatic status and antiplatelet therapy after coronary artery bypass graft surgery

Conditions: Graft Patency; Coronary Artery Bypass Grafting Surgery; Hypercoagulability; Thrombosis

Summary: the purpose of this study is to determine whether adding clopidogrel to aspirin after coronary bypass operation (cabg) improves graft patency, in patients that have preoperatively increased platelet activity(hypercoagulable) and therefore greater risk of graft occlusion( thrombosis).

graft patency after cabg is reported to 80-90% worldwide 1 year following surgery. in the immediate period after surgery, and the following month, graft occlusion mainly occurs due to thrombosis. patients with platelet hyperreactivity have increased risk of thromboembolic events, including graft occlusion, myocardial infarction and stroke. therefore intensifying the antiplatelet therapy in these patients, must be anticipated to have beneficial effects. hypercoagulable patients are identified with thrombelastography(teg) as having a maximal amplitude(ma)\>69, thereafter randomized to either clopidogrel(3months) and aspirin or aspirin alone. at 3 months postoperative after surgery the coronary graft patency is assessed with multislice ct scan. pre- and postoperatively, and then again at 3month followup, teg and multiplate aggregometry are performed to assess platelet reactivity and resistance to aspirin and clopidogrel.

Eligibility criteria:
inclusion criteria: * elective/subacute multivessel cabg * isolated cabg procedure, no concomitant surgery * age \> 18 years * able to give informed consent exclusion criteria: * myocardial infarction \<48h of surgery * prior cabg surgery within 1 month * cardiac shock within 48h of surgery * atrial fibrillation * anticoagulation therapy with vka * ich/tci within 30 days * prior peptic ulcer· platelet count \< 150 e9 * ongoing bleeding * known platelet disease * allergic to aspirin or clopidogrel * liver disease with elevated alat/asat\> 1,5x normal * creatinine\> 0,120mmol/l * contrast allergy * alcohol or narcotics abuse * pregnancy * not able to give informed consent * geographically not available for follow up

Keywords: saphenous vein antiplatelet therapy hypercoagulable clopidogrel resistance aspirin resistance clopidogrel aspirin saphenous vein graft disease teg thrombelastography multiplate aggregometry multislice ct coronary artery bypass graft surgery coagulation status graft patency cabg
lumbar drainage of intraventricular hemorrhage

Conditions: Intraventricular Hemorrhage; Lumbar Drainage; External Ventricular Drainage

Summary: intracerebral hemorrhage (ich) is a debilitating and fatal disease, especially when the hemorrhage is also entering the cerebral ventricles leading to acute hydrocephalus. in these cases, patients need a drainage through external ventricular drains (evd). in the longer term, patients often need a permanent ventriculoperitoneal (vp) shunt to avoid hydrocephalus. here we hypothesize that the early insertion of a lumbar drainage in addition to the evd could lead to better functional outcome and avoidance of vp shunting by drainage of the blood which promotes inflammatory and adverse effects in the subarachnoid space. for that we propose a multi-center randomized clinical trial to investigate the hypothesis.


Eligibility criteria:
inclusion criteria: * ich with ivh (with hemorrhage in the 3rd and/or 4rth ventricle) with the need for evd placement due to acute hydrocephalus * age ≥ 18 y * lumbar drain can be inserted within 72 h after symptom onset or patient last seen well exclusion criteria: * premorbid mrs score \> 2 * pregnancy * life expectancy \<6 months * patient/family/caregiver unwilling or unlikely to opt for at least two weeks of aggressive therapy prior to consideration of transition to comfort measures/discontinuation of life support measures. * treating physicians deeming the prognosis as so grave that an aggressive therapy is not warranted. * other clear contraindication for treatment with a lumbar drain
comparison of aurora fundus camera with traditional camera in diabetic retinopathy with visual artificial intelligence

Conditions: Diabetic Retinopathy

Summary: this study aims to compare the effect of aurora handheld fundus camera with traditional desktop fundus camera in the fundus photography screening of diabetic patients, and to evaluate the effect of artificial intelligence algorithm in the diagnosis of diabetic retinopathy.

aurora handheld fundus cameras are used to take fundus photography on diabetic patients in 3 ophthalmic diabetic retinopathy screening centers in china to compare its effect with the hospital's traditional desktop fundus camera, and evaluate the auxiliary diagnostic effect of phoebus artificial intelligence algorithm in diabetic retinopathy.

Eligibility criteria:
inclusion criteria: 1. participants are more than 18 years of age, male or female chinese patients; 2. diagnosed with diabetes; 3. prior written informed consent should be obtained exclusion criteria: 1. patients with invisible fundus caused by any cause; 2. patients or his/her licensor unwill to sign an informed consent or follow this protocol; 3. pregnant women

Keywords: aurora fundus camera artificial intelligence diabetic retinopathy